Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02249234

Acronym

ROBOT

Enrollment

Registered

2014-09-25

Start date

2014-08-31

Completion date

2018-10-31

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scrotal Pain

Keywords

Scrotal pain, Botox

Brief summary

There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with scrotal pain that we found published. We proposed a pilot study using Botox to block the nerves on a small group of men with chronic scrotal pain (CSP) who have failed the standard medical therapy. The men must have had temporary relief from a testicular cord block using local anaesthetic drug. The encourage results of the pilot study has given us the background information to proceed with a formal randomised control trial of Botox vs placebo. We hypothesized that Botox injections to block the testicular nerve will be effective in providing long term pain relief for men with scrotal pain.

Interventions

DRUGBotox

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Age 18-65 * Have nociceptive scrotal pain, * Have no identifiable, reversible causes for the scrotal pain * Have failed standard medical therapy * Have responded temporarily to cord blocks

Exclusion criteria

* Are interested in trying to conceive with their partners in the next 6 months, * Have any local infection near the site of the injections, * Have had an allergic reaction to Botox in the past, * Are unable to provide informed consent * Have a history of motor neuron disease or neurogenic bladder * Who have hemostatic disorder or who are taking aspirin, Coumadin (warfarin), Xarelto (rivaroxaban) or other blood thinners

Design outcomes

Primary

Measure	Time frame	Description
Reduction in the visual analog scales for pain	6 months after entering in trial	A measure of the change in the visual analog scales for pain.

Secondary

Measure	Time frame	Description
Reduction in scrotal pain	6 months after entering in trial	It will be assessed by the Chronic Epididymitis Symptom Index score.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026